Dose of Labeled Cholesterol for Kinetics: A Pilot Study

January 5, 2016 updated by: Ananda Basu, Mayo Clinic

Dose of Labeled Cholesterol and Phenylalanine for HDL Kinetics: A Pilot Study

This is a pilot study to determine the optimum time and dose to draw blood samples using a tracer for HDL kinetics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Healthy men and women ages 18 - 50

Exclusion Criteria:

  • Cardiovascular disease
  • Metabolic disease
  • Hematologic disorder
  • Liver or kidney disease
  • phenylketonuria
  • Currently taking lipid lowering medications or any other drugs that could affect lipid metabolism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tracer
Other: stable isotope of cholesterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incorporation of orally administered 13C3 cholesterol into plasma cholesterol
Time Frame: 72 hours
13C3 cholesterol, which is labeled with a stable isotope, will be administered orally. Blood samples will be taken every 4-6 hours for 72 hours for the measurement of stable isotopic enrichment in cholesterol using gas chromatography-mass spectrometry. The study has a dual purpose: to determine the optimum oral dose of isotope, and to determine the time of peak enrichment in plasma cholesterol.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: John M Miles, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-004890

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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